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Clinical Trials/NCT01241227
NCT01241227
Completed
Not Applicable

Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease. A Prospective Follow-up of 4,935 Person-years

Association HGE CHU Bordeaux Sud1 site in 1 country1,830 target enrollmentApril 2003
ConditionsLiver Fibrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Fibrosis
Sponsor
Association HGE CHU Bordeaux Sud
Enrollment
1830
Locations
1
Primary Endpoint
Overall survival
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.

Detailed Description

A total of 1616 patients with chronic hepatitis C was included. At 5 years, 79 patients were dead (39 liver-related deaths) and 16 patients had liver transplantation. Overall survival was 91.7% and survival without liver-related death 94.4%. Survival was significantly decreased in patients diagnosed with severe fibrosis, whatever the non-invasive method used. All these methods were able to predict a shorter survival in this large population. Patients had their prognosis decreased as liver stiffness increased. By multivariate analysis, only FibroTest \> 0.74 (OR 4.41, 95%CI 1.62-12.01, p=0.004) was associated with overall survival, and liver stiffness \> 9.5 kPa (OR 4.71, 95%CI 1.06-21.01, p=0.04) associated with liver-related death.

Registry
clinicaltrials.gov
Start Date
April 2003
End Date
February 2009
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Association HGE CHU Bordeaux Sud
Responsible Party
Principal Investigator
Principal Investigator

de Ledinghen

Professor

Association HGE CHU Bordeaux Sud

Eligibility Criteria

Inclusion Criteria

  • chronic hepatitis C
  • chronic hepatitis B
  • alcoholic liver disease
  • non alcoholic steatohepatitis

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Overall survival

Time Frame: 3 months

Secondary Outcomes

  • Survival without liver complications(3 months)
  • Survival without liver transplantation(3 months)

Study Sites (1)

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